What do we know about the safety and side effects of the Pfizer-BioNTech COVID-19 Vaccine in children and young teens in the 12- to 15-year-old age group?

Clinical trial results for the original monovalent Pfizer-BioNTech COVID-19 Vaccine (administered as a two-dose primary series) demonstrated that among vaccine recipients age 12–15 years, side effects during the 7 days after vaccination were commonly reported (90.9% of vaccine recipients reported a local reaction and 90.7% reported a systemic reaction). Most reactions were mild to moderate. Pain at the injection site was the most common local reaction. One in 10 reported a side effect that interfered with daily activities. Side effects usually resolved after 1–2 days. Systemic side effects (e.g., fever, fatigue, headache, muscle pain) were more commonly reported after the second dose than after the first dose. No specific safety concerns were identified among adolescent vaccine recipients.

The safety and side effects of the 2024–2025 formula approved in August 2024 are expected to be consistent with the previous formulations of the product.